Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)

Last updated: March 3, 2025
Sponsor: Gradient Denervation Technologies
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Congestive Heart Failure

Williams Syndrome

Treatment

Gradient Denervation System

Clinical Study ID

NCT06495970
CIP-003
  • Ages 22-85
  • All Genders

Study Summary

Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Mean Pulmonary Artery Pressure (mPAP) >20 mmHg at rest

  • Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest

  • Pulmonary Capillary Wedge Pressure > 15 mmHg (at rest) or > 18 with passive legraise

  • NYHA Class II or III

  • Glomerular Filtration Rate (GFR) ≥ 25 ml/min

Exclusion

Exclusion Criteria:

  • Unwilling to provide informed consent or complete follow-up assessments

  • Life expectancy of < 2 years

  • Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergyto aspirin or clopidogrel

  • Unable to tolerate right heart catheterization

  • Severe aortic, mitral or pulmonary valve regurgitation

  • Clot or Thrombus in any potential target ablation zone (right, left or mainpulmonary artery)

  • Systemic infection or localized infection/rash at planned access site at time ofprocedure

  • CRT, ICD, Pacemaker or other Interventional cardiac procedure (except RHC) withinthe last 3 months

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Gradient Denervation System
Phase:
Study Start date:
June 26, 2024
Estimated Completion Date:
June 30, 2026

Study Description

The Gradient Denervation System delivers ultrasound ablation to planned locations in the pulmonary artery to down-regulate the sympathetic nervous drive. The system includes a sterile, single-use catheter that is designed to centrally position the transducer within the arterial target zone for consistency of ablation.

Connect with a study center

  • Hospital Clínico Universitario de Valencia

    Valencia,
    Spain

    Active - Recruiting

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